Director, Clinical Management Operations
San Antonio, Texas
The Director of Clinical Operations is responsible for the oversight of the Project Management, IRB submittals, Quality Control of studies, and Coordinating staff in the conduction of studies.
The Director of Clinical Operations responsibilities include, but are not limited to, the following:
are interested, please contact John Nilon directly at 610-430-6800
or via e-mail.
- Always represents the comapny in a professional manner (verbal, written and in appearance) when interacting with sponsors, study subjects, outside vendors and fellow employees.
- Oversees all aspects of clinical trials management for Phase I-IIB clinical trials.
- Oversees the management of staff in the areas of Clinical Study Conduct and Project Management.
- Supervises full-time, part-time, contract and PRN Project Managers, Study Conduct Managers, and Clinical Management Staff.
- Directs clinical staff to work together to plan, recruit and conduct clinical trials, meeting Sponsor, company and regulatory requirements.
- Projects staffing needs in advance to ensure trained coverage for all studies.
- Meets with Sponsors on a regular basis to gauge staff performance.
- Ensures that all research activities comply with company policies and procedures, sponsor expectations and Federal guidelines.
- Provides operational expertise, leadership and guidance to the staff.
- Reviews systems for efficiencies on a continual basis.
- Works with his/her Supervisor to review studies for feasibility and schedule workload for clinic.
- Works with Business Development Group to promote the capabilities and services of the Phase I unit.
- Assures clinical timelines are met and the best quality product is delivered.
- Reviews quality reports on a monthly basis. Investigates any action items and ensures any corrective action, if needed, is implemented as soon as possible. Reports back to QA department.
- Works closely within Company to develop a good, working relationship to ensure projects run smoothly.
- Attends and is prepared to help with study initiation meetings, sponsor site visits and any audits.
- Responsible for supervisory staff evaluations.
- Works closely with staff at all facilities to ensure procedures are performed consistently.
- Works closely with the Associate Directors of Medical/Technical and Support Services and all other departments to ensure good study communication and teamwork.
- Helps train staff as needed.
- Verifies and signs timesheets.
- Mentors employees and address performance issues.
- Responsible for requesting, scheduling and attending any training required for this position.
- Continually works on improving processes and procedures to increase quality of work and work flow efficiencies.
- Continually looks for ways to motivate and team build staff across all departments.